Comparing anticoagulation strategies after brain hemorrhage in patients with atrial fibrillation
Avoiding Anticoagulation After IntraCerebral Haemorrhage
This study is testing three different ways to prevent future blood clots in people with atrial fibrillation who have had a brain bleed to see which method works best.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 3 sites (Lille and 2 other locations) |
| Trial ID | NCT03243175 on ClinicalTrials.gov |
What this trial studies
This clinical trial is an open-label, randomized controlled multicenter study designed to evaluate three different strategies for managing patients with a history of intracerebral hemorrhage (ICH) and atrial fibrillation (AF). Participants will be assigned to one of three groups: those receiving direct oral anticoagulation with Apixaban, those undergoing left atrial appendage closure, and those receiving usual care without anticoagulation. The primary outcome will assess the net clinical benefit, which includes major ischemic and hemorrhagic events over a 24-month follow-up period. The results aim to guide clinicians in determining the most effective treatment strategy for preventing future vascular events in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a documented history of non-valvular atrial fibrillation and a prior spontaneous intracerebral hemorrhage.
Not a fit: Patients with serious bleeding events in the past six months or those requiring long-term anticoagulation for conditions other than atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safest and most effective management strategies for patients with atrial fibrillation who have experienced an intracerebral hemorrhage.
How similar studies have performed: While studies have explored anticoagulation in atrial fibrillation, this specific approach addressing patients with prior intracerebral hemorrhage is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Adult (older than 18 years old, no upper age limit) * with a history of paroxysmal, persistent or long-standing non-valvular atrial fibrillation (documented on an electrocardiogram) * and a CHA2DS2VASc score of 2 or more who have an indication for long-term anticoagulation * who suffered from a spontaneous intracerebral haemorrhage (while being treated with oral anticoagulants or not) documented with brain CT or MRI * more than 14 days before randomization (no upper delay limit) * for whom there is a clinical equipoise regarding the choice of the best preventive strategy to avoid future vascular events. Exclusion criteria for all treatment groups * Pre-randomisation modified Rankin score of 4 or 5 * Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve) * Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage) * Life expectancy of less than 1 year * Pregnancy or breastfeeding Exclusion criteria related to the LAAC only * Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis) * Patients older than 85 years * CHA2DS2VASc score of 2 or 3 * Patient or attending physician are unwilling to undergo/perform intervention for LAAC Exclusion criteria related to the Direct OAC only * Chronic renal insufficiency (clearance of creatinine by Cockcroft method \< 30ml/min) * Body weight lower than 50 kg * Allergy to apixaban * Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders) * Patient or attending physician are unwilling to use of Direct OAC
Where this trial is running
Lille and 2 other locations
- Hôpital Roger Salengro, CHU — Lille, France (Recruiting)
- Ghicl — Lomme, France (Recruiting)
- CH De Tourcoing — Tourcoing, France (Recruiting)
Study contacts
- Principal investigator: Charlotte Cordonnier, MD, PhD — University Hospital Lille, Inserm, Univ Lille
- Study coordinator: Charlotte Cordonnier, MD, PhD
- Email: charlotte.cordonnier@chru-lille.fr
- Phone: 3 20 44 68 14
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.